Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Portal vein embolization plus hepatic artery embolization
Control group:hepatic artery embolization
Sponsors
Yuebei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-80 years old; 2. Patients with primary hepatocellular carcinoma who strictly comply with the clinical diagnostic criteria of the code for diagnosis and treatment of primary liver cancer (version 2019) or confirmed by histopathology or cytology; single tumor, diameter > 10cm; or multiple tumors, imaging standards can not be one-stage radical resection; no vascular, bile duct and adjacent organ invasion and distant metastasis. 3. Child Pugh liver function rating: Grade A or better grade B (= 90 g/L ANC >= 1.5 x 10^9/L PLT >= 60 x 10^9/L (2) Biochemical examination: ALB >= 2^9 g/L ALT and AST < 2.5ULN; TBIL <= 2ULN Creatinine <= 1.5ULN; (only one of the two indicators of albumin and bilirubin in child Pugh rating is 2 points). 9. Women of childbearing age should exclude the possibility of pregnancy before entering the group; 10. The subjects who volunteered to join the study had no mental illness or other mental symptoms, had full civil capacity, signed informed consent, good compliance, and could cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with one-stage radical resection by imaging diagnosis; 2. Patients with CNLC stage IIB liver cancer who are not suitable for radiofrequency ablation; 3. Patients with vascular, bile duct and adjacent organ invasion and distant metastasis; 4. Patients who received any local treatment (including but not limited to surgery, radiotherapy, cryoablation or percutaneous ethanol injection) within 4 weeks before participating in the study; five Subjects with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, adult does not need any treatment) Intervention can be included; subjects need bronchodilator for medical intervention of asthma can not be included); 6. Subjects who are using immunosuppressant or systemic or absorbable local hormone to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other effective hormones) and continue to use them within 2 weeks before enrollment; 7. Subjects with severe allergic reaction to the test drug; 8. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA grade 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmias with clinical significance need treatment or intervention; (5) QTc > 450 ms (male), QTc > 470 MS (female). 9. Patients with abnormal coagulation function (INR > 1.5 or PT > 16S) have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Subjects who had previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy and were less than 4 weeks away from the last medication or treatment (or 5 drug half lives, whichever is longer); patients whose adverse events (except alopecia) caused by previous treatment did not return to 38.5 degree during screening or before the first administration; 15. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function; 16. Subjects with congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBV DNA detecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Countries
China
Contacts
Public ContactCongyun Huang
Yuebei People's Hospital
Outcome results
None listed